Filing an Electronic Disclosure with COI SMART

A conflict of interest can jeopardize the integrity, objectivity, and viability of Downstate research projects. In addition, State, Federal and sponsor scrutiny leave little room for error in identifying and managing these conflicts.

COI SMART is a web-based application that automates and organizes the process of conflict of interest disclosure. Its automated interface features a 'smart form' that enables users to quickly and conveniently submit the Downstate Financial Disclosure Form. COI SMART will maintain electronic copies of all Investigators' Form submissions, and, for your convenience, COI SMART will auto-populate previously submitted information / answers so they will not have to be re-entered year after year. COI SMART has security controls that enable disclosures to be maintained securely and privately.

COI Electronic Disclosures - Who Must File

Conflicts of Interest Disclosure Forms must be submitted by all funded and unfunded Investigators.

Investigator: An Investigator, for COI purposes, is defined as the project director, Principal Investigator, co-Principal Investigator, or any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research. The PI is responsible for identifying all Investigators involved in their research activities. If the role of an individual is unclear and that individual has been previously designated as an Investigator, compliance with all training and filing requirements will be expected.

Staff and trainees, such as postdoctoral fellows, graduate and medical students, residents and fellows, and technicians who perform research tasks (including, but not limited to: recruit patients, collect data, handle data, enter data into an electronic capturing system, perform experiments, implement a protocol) under supervision but are not responsible for the design/conduct/reporting of research are not considered Investigators for purposes of COI.

Any individual who is required to submit a Conflicts of Interest Disclosure Form must also complete Conflicts of Interest Training.

Principal Investigators may submit this completed COI Registration Form to Compliance@downstate.edu to request Downstate personnel enrollment in Conflicts of Interest requirements.

COI Electronic Disclosures - When and How to File

Disclosures are required in four instances:

1. Annual Disclosures: The Downstate Financial Disclosure form for all Investigators must be submitted on an annual basis.
2. Submission of Application for Grant/Award: Investigators are required to submit the Downstate Transactional Disclosure Form (Declaration of Research Project) at the time of an application for a sponsor grant or award.
3. Submission of an IRB Protocol for Human Research: Investigators are required to submit the Downstate Transactional Disclosure Form (Declaration of Research Project) at the time of submission of an IRB protocol for unfunded research, at the time of an amendment to be added to an IRB application and at the time of IRB Continuing Review.
4. New Disclosures: An updated Downstate Financial Disclosure Form must be submitted within thirty (30) days of a new Outside Activity or interest that falls under this policy.

Please note that Investigators who do not complete an annual disclosure and/or a required declaration of new research project transactional questionnaire will be restricted from study approval and will have holds placed on any award account expenditures. This pertains to all research staff who meet the COI definition of "Investigator" as identified by the Principal Investigator for each particular study

CLICK HERE TO LOG-ON TO DOWNSTATE'S ELECTRONIC DISCLOSURE SYSTEM - COI SMART